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Malignant MelanomaPhase 2NCT05664139

Recombinant Human Adenovirus Type 5 Injection Combined With PD-1 Monoclonal Antibody and Nab-paclitaxel in the Treatment of Patients With Liver Metastases From Malignant Melanoma

A Phase 2 study testing Recombinant Human Adenovirus Type 5 Injection,Camrelizumab,Nab-paclitaxel in people with Malignant Melanoma and Liver Metastases, run by Fujian Cancer Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is the first to explore the efficacy and safety of recombinant human adenovirus type 5 injection combined with PD-1 monoclonal antibody and nab-paclitaxel in the treatment of patients with liver metastases of melanoma, in order to provide a new method for the clinical treatment of melanoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Melanoma, Liver Metastases
What is being tested?
Recombinant Human Adenovirus Type 5 Injection,Camrelizumab,Nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Feb 2023to Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old, and ≤ 75 years old, gender is not limited;
  • Patients with liver metastasis of malignant melanoma diagnosed by histopathology;
  • There must be an injectable lesion in the liver, and the lesion must meet the requirements of RECIST 1.1 measurable target lesion;
  • The liver lesion needs to be judged by the surgeon to have a poor prognosis in biological behavior; or the surgeon judges that it can be resected, but the patient refuses the operation, and the liver metastases must meet the following requirements:
  • The number of metastatic lesions should not exceed 5, and the sum of the longest diameters of the total metastatic lesions must be ≤100mm;
  • The longest diameter of a single lesion ≤ 100 mm;
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  • The longest diameter of the injection lesion must be ≥10mm and ≤80mm;
  • ECOG physical condition score 0-1 points;
  • Expected survival time > 3 months;
  • Laboratory examinations meet the following standards:
  • White blood cell count ≥3.0×109/L, absolute value of neutrophils ≥3.0×109/L, platelet count ≥100×109/L, hemoglobin ≥90g/L;
  • International normalized ratio (INR) ≤ 1.5, and activated partial thromboplastin time (APTT) ≤ 1.5 × upper limit of normal (ULN) or partial prothrombin time (PTT) ≤ 1.5 × ULN;
  • Total bilirubin ≤ 1.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN;
  • Serum creatinine ≤1.5×ULN or creatinine clearance ≥50ml/min at 24 hours.
  • The interval between the date of the first treatment in this study and the date of the last anti-tumor treatment in the past is ≥14 days, and the adverse reactions of the previous anti-tumor treatment have recovered to baseline or below grade 1 [evaluation criteria for common adverse events (CTCAE version 5.0)] (hair loss and grade 2 anemia);
  • Volunteer to participate in this study and sign the informed consent;
  • Female patients of childbearing age or male patients whose sexual partner is female of childbearing age should take effective contraceptive measures throughout the treatment period and 6 months after the last medication.

Who cannot join

  • Bone metastasis, lymph node metastasis, brain metastasis and other metastatic malignant melanoma;
  • njectable lesions have previously received other local treatments such as ablation, intervention, and Haifu Knife;
  • Patients who have previously received oncolytic virus drugs (such as T-VEC) or other similar drugs;
  • Patients who have previously received PD-1/PD-L1/PD-L2 therapy;
  • Local lesions cannot meet the volume requirements for intratumoral injection or are not suitable for intratumoral injection;
  • Accompanied by malignant pleural effusion and ascites;
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  • Patients who are positive for hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antibody;
  • People who are known to be allergic to the study drug or its active ingredients, or have a history of allergy to similar biological agents;
  • Received antiviral drug treatment within 4 weeks before enrollment, such as acyclovir, ganciclovir, valaciclovir, vidarabine, etc.;
  • Received any other experimental drugs or participated in other interventional clinical trials within 4 weeks before enrollment;
  • Pregnant or lactating women, men or women who are unwilling to take effective contraceptive measures;
  • Vulnerable groups: including the mentally ill, critically ill subjects, minors, cognitively impaired, etc.;
  • Child-Pugh C Evidence of liver function or hepatocyte decompensation, including refractory ascites, bleeding from esophageal or gastric varices, and hepatic encephalopathy;
  • There is a history of immunodeficiency or autoimmune disease, or receiving long-term systemic steroid therapy or any form of immunosuppressive therapy within 7 days before enrollment;
  • Patients with a history of active tuberculosis (TB), active hepatitis, patients who have been evaluated for oral nucleoside (acid) analogues, known human immunodeficiency virus (HIV) positive patients, other serious infections that require treatment, and those who are taking anti-inflammatory drugs Viral drugs or large doses of adrenal corticosteroids;
  • Accompanied by any unstable systemic diseases, including but not limited to: hypertensive patients whose blood pressure cannot be lowered to normal, uncontrolled diabetes, cerebrovascular accident or transient cerebral ischemia, mental abnormality or active cerebral hemorrhage, not Stable angina, myocardial infarction (a history of myocardial infarction of 6 months or more is allowed), congestive heart failure, severe arrhythmia requiring drug therapy, severe cardiopulmonary disease abnormality, renal or metabolic disease, severe liver dysfunction ( including severe jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome);
  • Having other malignant tumors in the past or at the same time, except for the following: stage I uterine cancer that has been radically cured, localized prostate cancer that is currently considered cured after radical surgery, and other solid tumors that have been cured for more than 5 years and have no signs of recurrence;
  • Known central nervous system tumors, including metastatic brain tumors;
  • Combined with medical contraindications that cannot accept any contrast-enhanced imaging examination (CT or MRI);
  • The investigator judges that the patient has other conditions that are not suitable for participating in this study.

Trial locations and contacts

No sites are listed yet.

Yu Chen, PhD contact

13859089836

13859089836@139.com

About this study

Official title: A Prospective, Single-arm Study on the Efficacy and Safety of Recombinant Human Adenovirus Type 5 Injection Combined With PD-1 Monoclonal Antibody and Nab-paclitaxel in the Treatment of Patients With Liver Metastases From Malignant Melanoma

This study is the first to explore the efficacy and safety of recombinant human adenovirus type 5 injection combined with PD-1 monoclonal antibody and nab-paclitaxel in the treatment of patients with liver metastases of melanoma, in order to provide a new method for the clinical treatment of melanoma. The model also provides reference and basis for other tumor treatments.

Being tested
Recombinant Human Adenovirus Type 5 Injection,Camrelizumab,Nab-paclitaxel
Keywords
recombinant human adenovirus type 5, Camrelizumab, Nab-paclitaxel, Malignant Melanoma, Liver Metastases
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant Human Adenovirus Type 5 Injection,Camrelizumab,Nab-paclitaxelDrug

    Recombinant Human Adenovirus Type 5 Injection:①the longest diameter of the lesion≥10mm and≤40mm, inject 1ml into the tumor each time;②the longest diameter of the lesion≥40mm and≤80mm, inject 2ml into the tumor each time. planned injections at D1. Every 3 weeks is a period, a total of 4 cycles; if there are visceral and superficial lesions at the same time, the injection lesions will be selected by the investigator based on possible benefits.

    Camrelizumab:200mg/time.Intravenous within 48 hours after injection of recombinant human adenovirus type 5 injection. Every 3 weeks is a period, and the treatment is continued until the subject has disease progression or unacceptable toxicity or death.

    Nab-paclitaxel:260mg/m2, D1, every 3 weeks as a period, a total of 4-6 cycles (determined by the investigator), or continue treatment until the subject has disease progression or Intolerable toxicity or death.

Study groups in NCT05664139
Study groupRoleWhat they receive
Experimental ArmExperimental* Recombinant Human Adenovirus Type 5 Injection: 1ml or 2ml, d1, q3w, 4 cycles; * Camrelizumab: 200mg, d2, q3w; * Nab-paclitaxel: 260mg/m2, d1, q3w, 4-6 cycles;
Receives: Drug: Recombinant Human Adenovirus Type 5 Injection,Camrelizumab,Nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective tumor response rate (ORR)

    From the first administration of the study drug to disease progression, unacceptable toxicity, withdrawal of informed consent or termination of the study (up to 1 year), including the proportion of CR and PR among all patients.

    Measured: 1 year

Secondary outcomes (5)

  1. Disease control rate (DCR)

    It refers to the proportion of patients whose tumor shrinks or stabilizes and keeps for a certain period of time, including CR, PR and SD cases among all patients.

    Measured: 1 year

  2. Progression-free survival (PFS)

    The time (days) from the date of randomization to the first observation of disease progression (based on imaging), if the patient died of other causes before disease progression, the time from the date of randomization to death was calculated number of days.

    Measured: 1 year

  3. One-year Overall Survival

    1-year overall survival rate

    Measured: 1 year

  4. Quality of life (QoL)

    EORTC QLQ-C30

    Measured: 1 year

  5. Adverse event collection

    Incidence of adverse reactions

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2022
  2. Study startFeb 2023 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05664139
Sponsor's protocol ID
FJCH-HR-001
Status last verified
Dec 2022
First submitted
8 Dec 2022
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant Human Adenovirus Type 5 Injection,Camrelizumab,Nab-paclitaxel in people with Malignant Melanoma and Liver Metastases, run by Fujian Cancer Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yu Chen, PhD (13859089836, 13859089836@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective tumor response rate (ORR) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05664139.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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